EDWARDS INTUITY Valve System CADENCE Study

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Edwards Lifesciences

Status

Completed

Conditions

Aortic Valve Disease
Aortic Stenosis

Treatments

Device: Stented aortic bioprostheses
Device: EDWARDS INTUITY

Study type

Interventional

Funder types

Industry

Identifiers

NCT02688153
2011-11

Details and patient eligibility

About

The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.

Full description

This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical aortic valve replacement surgery with concomitant coronary bypass grafts. Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and finally to explore additional healthcare resource utilization or health economic endpoints.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

  • ≥18 years of age
  • aortic stenosis / mixed aortic stenosis and aortic insufficiency
  • SAVR+CABG (1-4 distal anastomoses)
  • Log. EuroSCORE ≥6
  • NYHA Class ≥II

Exclusion (i.a.):

  • pure aortic insufficiency
  • pre-existing prosthetic heart valve or ring
  • congenital true bicuspid / unicuspid aortic valve
  • LVEF <20%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

EDWARDS INTUITY
Active Comparator group
Description:
EDWARDS INTUITY Valve System, Model 8300A
Treatment:
Device: EDWARDS INTUITY
Stented aortic bioprostheses
Active Comparator group
Description:
Stented aortic bioprostheses
Treatment:
Device: Stented aortic bioprostheses

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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